Manager (Clinical Development)

Brief team/department description:

As part of the Clinical Development team at Azurity, the Manager, Clinical Development is a contributor to early development activities in support of product evaluation and testing across multiple therapeutic areas.

In this role, the candidate will report to the Director, Clinical Development and work with stakeholders and team members to provide scientific excellence, build effective relationships across R&D, and ensure optimal design and analysis of clinical investigations.

Principle Responsibilities:

• Design studies including technical, regulatory and formulation aspects.
• Collaborate with respective program manager and study teams to develop study plans and ensure alignment with overall development plan, key milestones and timelines.
• Ensures compliance of clinical study with GCP, local and target regulatory guidelines, study protocol; identifies areas of concern, and enacts contingences when appropriate.
• Oversees study operations* including and not limited to study initiation, monitoring and closeout, sample shipment and routine follow-up and communication with CROs. (* This involves travelling to the CRO locations and study sites.)
• Can independently perform non-compartmental PK analysis, PK (or PBPK) modeling and IVIVC (preferable); communicate trial status and data to cross-functional teams.
• Oversee data repository, TMF, other critical study documents, such as consent forms, study manuals, subject recruitment materials.
• Propose alternative study operation strategies to optimize use of time, cost and resource.
• Contribute to the development, review, and approval of clinical study documents including but not limited to ICF, investigator s brochure (IB), study plans, CRFs, pharmacy and laboratory manuals, clinical study reports, and regulatory documents.

Qualifications and Education Requirements

This section should include relevant qualifications and education requirements.

• Master s, Pharm.D, or Ph.D degree preferred in the field of clinical research or equivalent field, pharmacology, pharmaceutics.
• Minimum of 6 years of pharmaceutical industry experience with at least 4-5 years of experience in Phase 1 (or 2) clinical development preferred.
• Sound understanding of US and ex-US regulatory clinical requirements and experience of working in 505.b.2 pathway-based drug development, continuum with thorough knowledge of regulatory approval processes.
• Knowledge in ICH guidelines and GCP; experience of clinical trial designing and methodologies utilized in clinical pharmacology studies.
• Experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics.
• Have proven track record of working on Winnonlin or other PK software for non-compartmental-based analysis, steady-state simulations, compartmental models and their utilities for dose and regimen finding.
• Strong organizational, interpersonal and both verbal and written communication skills and ability to work collaboratively as a member of a cross-functional team.
• Exceptional analytical and problem-solving skills.
• Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely.